AccessGUDID - DEVICE: ManaMed (00810113681382)

GUDID

Device Identifier (DI) Information

Brand Name: ManaMed
Version or Model: ManaOA HD, LFT, PB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MANAOA01L
Company Name: Manamed, Inc.

Primary DI Number: 00810113681382
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: ManaOA is a lightweight, low-profile single upright osteoarthritis knee brace with unique varus/valgus angle adjustment to optimize pain relief. Laterally applied frame and hinge corrects for either medial or lateral compartment and avoids contralateral limb contact during walking. Indication: Mild to severe unicompartmental osteoarthritis, Medial or lateral compartment Features & Benefits: Single upright OA brace. Set-Fit Buckle System that eliminates the hassle of Velcro® adjustments. Maximized 3 points of leverage for medical compartment. Q-Hinge corrects by changing the overall angle of the brace rather than pushing or pulling with the straps or condyle pads. Available in heavy-duty Q-hinge for patients over 300 pounds.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41065	Knee support orthosis	A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITQ	Joint, Knee, External Brace

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb4bb2ad-5476-4622-8663-3b9fd3ba6d0a
Public Version Date: July 11, 2024
Public Version Number: 3
DI Record Publish Date: June 23, 2022